HealthyPhase 1NCT04631562

Study of ALXN1820 in Healthy Adult Participants

A Phase 1 study testing ALXN1820 SC and ALXN1820 IV in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1820 administered subcutaneously (SC) (ALXN1820 SC) and intravenously (IV) (ALXN1820 IV). Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: ALXN1820 SC and ALXN1820 IV
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 3 sitesin 2 countries
Study dates: 13 Jan 2021to 1 Sep 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Body weight 50 to 100 kilograms (kg); body mass index 17 to 32 kg/meter squared.
Cohort 9 only: Japanese participants (defined as those participants whose parents and grandparents are both Japanese and who have spent less than 5 years outside of Japan).
Satisfactory medical assessment.
Must follow protocol-specified contraception guidance while on treatment and for up to 6 months after last dose.
Vaccination requirement:
Vaccination with tetravalent meningococcal conjugate vaccine at least 56 days and not more than 2 years, 6 months prior to dosing;
Vaccination with serogroup B meningococcal vaccine at least 56 days prior to dosing, with a booster at least 28 days prior to dosing, with at least 28 days between the first and second injections.

Who cannot join

Current/recurrent diseases or relevant medical history.
History of any Neisseria infection.
Hepatitis B/C, human immunodeficiency virus.
History of latent or active tuberculosis (TB), or positive TB test.
Active systemic infection within 14 days of dosing.
Risk of meningococcal infections due to living/working conditions.

Show all 10Show fewer

History of complement deficiency or complement activity below the reference range.
Participation in a clinical study within 90 days or 5 half lives of the investigational agent (whichever is longer) before initiation of dosing on Day 1.
Participation in more than 1 clinical study of a monoclonal antibody (mAb), or participation in a clinical study of a mAb within the 6 months or 5 half lives of the mAb (whichever is longer) prior to screening.
Acquired complement deficiencies (for example, those receiving eculizumab).

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

United Kingdom2 sites

Research Site
London, SE1 1YR
Research Site
London, SE5 9RS

Other trials in United Kingdom

Australia1 site

Research Site
Herston, 4006

Other trials in Australia

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of Subcutaneous and Intravenous ALXN1820 in Healthy Participants

Read the detailed description

This study will include up to 10 different dosing cohorts, with each cohort consisting of 2 groups (ALXN1820 group, placebo group). Participants will be randomly assigned in a 3:1 ratio to each of these 2 groups, respectively, within all 10 cohorts, to receive either a single or multiple doses of ALXN1820 SC, a single dose of ALXN1820 IV, or a single or multiple doses of placebo.

The study will be conducted in healthy adult participants and will also include a multiple SC dose cohort in healthy participants of Japanese descent.

Conditions: Healthy
Being tested: ALXN1820 SC, ALXN1820 IV, Placebo SC, Placebo IV
Keywords: ALXN1820, Properdin, Pharmacodynamics, Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALXN1820 SCDrug
ALXN1820 SC will be administered as a manual SC push or SC infusion via a syringe pump. Doses will range from 12.5 milligrams (mg) to a maximum of 2250 mg. Multiple dosing duration will range from 3 to 5 weeks.
ALXN1820 IVDrug
ALXN1820 IV (450 mg) will be administered as an IV infusion.
Placebo SCDrug
Placebo SC will be administered as a manual SC push or SC infusion via a syringe pump.
Placebo IVDrug
Placebo IV will be administered as an IV infusion.

Study groups in NCT04631562
Study group	Role	What they receive
ALXN1820	Experimental	Participants will receive ALXN1820 SC or ALXN1820 IV according to their assigned cohort. ALXN1820 SC will be evaluated in single and multiple ascending doses while ALXN1820 IV will be evaluated in a single dose cohort only. Receives: Drug: ALXN1820 SC; Drug: ALXN1820 IV
Placebo	Placebo comparator	Participants will receive Placebo SC or Placebo IV according to their assigned cohort. Receives: Drug: Placebo SC; Drug: Placebo IV

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-related Adverse Events (TEAEs) For ALXN1820 SC And ALXN1820 IV
An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as any AEs that commenced after the start of administration of study intervention. Serious AEs (SAEs) were defined as any untoward medical occurrence that met at least 1 of the following serious criteria: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, other medically important serious event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported AEs' Section.
Measured: Cohorts 1 to 6: Baseline up to Day 127; Cohorts 8 to 9: Baseline up to Day 155

Secondary outcomes (12)

Area Under The Concentration-time Curve (AUC) From Time 0 (Dosing) To Time Infinity (AUC0-inf) And AUC During The Dosing Interval (AUCtau) of Serum ALXN1820 For Single Dose Cohorts
Measured: Up to 126 days following the first day of dosing
Area Under The Concentration-time Curve During The Dosing Interval (AUCtau) Of Serum ALXN1820 For Multiple Dose Cohorts
Measured: Up to 154 days following the first day of dosing
Maximum Observed Serum Concentration (Cmax) Of Serum ALXN1820 For Single Dose Cohorts
Measured: Up to 126 days following the first day of dosing
Maximum Observed Serum Concentration (Cmax) Of Serum ALXN1820 For Multiple Dose Cohorts
Measured: Up to 154 days following the first day of dosing
Change From Baseline in Serum Concentrations Of Total Properdin For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts
Measured: Baseline, Day 127
Change From Baseline in Serum Concentrations Of Free Properdin For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts
Measured: Baseline, Day 127
Change From Baseline In Serum Concentrations of Total Properdin For ALXN1820 SC- Multiple Dose Cohorts
Measured: Baseline, Day 155
Change From Baseline In Serum Concentrations of Free Properdin For ALXN1820 SC- Multiple Dose Cohorts
Measured: Baseline, Day 155
Change From Baseline In Complement Alternative Pathway (CAP) Activity Using The Wieslab Alternative Pathway (AP) Assay For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts
Measured: Baseline, Day 127
Change From Baseline In Complement Alternative Pathway Activity Using The Wieslab Alternative Pathway Assay For ALXN1820 SC- Multiple Dose Cohorts
Measured: Baseline, Day 155
Number Of Participants With Positive Antidrug Antibodies (ADAs) To ALXN1820 SC And ALXN1820 IV
Measured: Baseline up to Day 155
Absolute Bioavailability Of ALXN1820 SC
The absolute bioavailability was expressed as ratio and was calculated as the geometric mean for the AUC[0-inf] for SC divided by the geometric mean for the AUC[0-inf] for IV. Least square means were calculated with cohort, treatment, and sequence as the fixed effects, and participant-participant (sequence) as a random effect.
Measured: Baseline up to Day 127

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jan 20211 Sep 2022

First posted17 Nov 2020
Study start13 Jan 2021
Primary completion1 Sep 2022
Study completion1 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04631562
Sponsor's protocol ID: ALXN1820-HV-101
Other IDs: 2021-002472-39
Status last verified: Jul 2024
First submitted: 13 Nov 2020
Last updated: 20 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sandhu A, Shen T, Herrero PM, Yuan CX, Qureshi S, Jiang X, Sheng Y, Gasteyger C, Dai Y. Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ALXN1820 (Tarperprumig) in Healthy Adults: Results of a Phase I Study. Clin Transl Sci. 2025 Apr;18(4):e70190. doi: 10.1111/cts.70190.
PubMed 40134111

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of Subcutaneous and Intravenous ALXN1820 in Healthy Participants
ClinicalTrials.gov ID: NCT04631562
Acronym / sponsor ID: ALXN1820-HV-101
Conditions: Healthy
Keywords: ALXN1820, Properdin, Pharmacodynamics, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Syneos Health
Study start: 13 Jan 2021 (actual)
Primary completion: 1 Sep 2022 (actual)
Study completion: 1 Sep 2022 (actual)
First posted: 17 Nov 2020 (actual)
Results: Posted 15 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will be conducted in healthy adult participants and will also include a multiple SC dose cohort in healthy participants of Japanese descent.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
ALXN1820	Experimental	Drug: ALXN1820 SC, Drug: ALXN1820 IVParticipants will receive ALXN1820 SC or ALXN1820 IV according to their assigned cohort. ALXN1820 SC will be evaluated in single and multiple ascending doses while ALXN1820 IV will be evaluated in a single dose cohort only.
Placebo	Placebo comparator	Drug: Placebo SC, Drug: Placebo IVParticipants will receive Placebo SC or Placebo IV according to their assigned cohort.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Body weight 50 to 100 kilograms (kg); body mass index 17 to 32 kg/meter squared.
Cohort 9 only: Japanese participants (defined as those participants whose parents and grandparents are both Japanese and who have spent less than 5 years outside of Japan).
Satisfactory medical assessment.
Must follow protocol-specified contraception guidance while on treatment and for up to 6 months after last dose.
Vaccination requirement:

Key exclusion criteria (10 listed)

Current/recurrent diseases or relevant medical history.
History of any Neisseria infection.
Hepatitis B/C, human immunodeficiency virus.
History of latent or active tuberculosis (TB), or positive TB test.
Active systemic infection within 14 days of dosing.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALXN1820 SCALXN1820 SC will be administered as a manual SC push or SC infusion via a syringe pump. Doses will range from 12.5 milligrams (mg) to a maximum of 2250 mg. Multiple dosing duration will range from 3 to 5 weeks.	Drug	ALXN1820
ALXN1820 IVALXN1820 IV (450 mg) will be administered as an IV infusion.	Drug	ALXN1820
Placebo SCPlacebo SC will be administered as a manual SC push or SC infusion via a syringe pump.	Drug	Placebo
Placebo IVPlacebo IV will be administered as an IV infusion.	Drug	Placebo

Primary outcome

Number of Participants With Treatment-related Adverse Events (TEAEs) For ALXN1820 SC And ALXN1820 IV
Time frame: Cohorts 1 to 6: Baseline up to Day 127; Cohorts 8 to 9: Baseline up to Day 155
An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as any AEs that commenced after the start of administration of study intervention. Serious AEs (SAEs) were defined as any untoward medical occurrence that met at least 1 of the following serious criteria: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, other medically important serious event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported AEs' Section.

12 secondary outcomes

Area Under The Concentration-time Curve (AUC) From Time 0 (Dosing) To Time Infinity (AUC0-inf) And AUC During The Dosing Interval (AUCtau) of Serum ALXN1820 For Single Dose Cohorts
Time frame: Up to 126 days following the first day of dosing
Area Under The Concentration-time Curve During The Dosing Interval (AUCtau) Of Serum ALXN1820 For Multiple Dose Cohorts
Time frame: Up to 154 days following the first day of dosing
Maximum Observed Serum Concentration (Cmax) Of Serum ALXN1820 For Single Dose Cohorts
Time frame: Up to 126 days following the first day of dosing
Maximum Observed Serum Concentration (Cmax) Of Serum ALXN1820 For Multiple Dose Cohorts
Time frame: Up to 154 days following the first day of dosing
Change From Baseline in Serum Concentrations Of Total Properdin For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts
Time frame: Baseline, Day 127
Change From Baseline in Serum Concentrations Of Free Properdin For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts
Time frame: Baseline, Day 127
Change From Baseline In Serum Concentrations of Total Properdin For ALXN1820 SC- Multiple Dose Cohorts
Time frame: Baseline, Day 155
Change From Baseline In Serum Concentrations of Free Properdin For ALXN1820 SC- Multiple Dose Cohorts
Time frame: Baseline, Day 155
Change From Baseline In Complement Alternative Pathway (CAP) Activity Using The Wieslab Alternative Pathway (AP) Assay For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts
Time frame: Baseline, Day 127
Change From Baseline In Complement Alternative Pathway Activity Using The Wieslab Alternative Pathway Assay For ALXN1820 SC- Multiple Dose Cohorts
Time frame: Baseline, Day 155
Number Of Participants With Positive Antidrug Antibodies (ADAs) To ALXN1820 SC And ALXN1820 IV
Time frame: Baseline up to Day 155
Absolute Bioavailability Of ALXN1820 SC
Time frame: Baseline up to Day 127

Results and safety

Results posted to the registry on 15 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: ALXN1820 12.5 mg SC	5	5
Cohort 2: ALXN1820 50 mg SC	6	6
Cohort 3: ALXN1820 150 mg SC	5	5
Cohort 4: ALXN1820 450 mg SC	5	4
Cohort 5: ALXN1820 450 mg IV	5	5
Cohort 6: ALXN1820 1200 mg SC	6	6
Cohort 8: ALXN1820 150 mg SC (QW*5)	7	6
Cohort 9: ALXN1820 150 mg SC (QW*5)	6	5
All Placebo	15	14

Primary outcome: Number of Participants With Treatment-related Adverse Events (TEAEs) For ALXN1820 SC And ALXN1820 IV

Time frame: Cohorts 1 to 6: Baseline up to Day 127; Cohorts 8 to 9: Baseline up to Day 155. Count of participants. Unit: Participants

Measure	Cohort 1: ALXN1820 12.5 mg SC n = 5	Cohort 2: ALXN1820 50 mg SC n = 6	Cohort 3: ALXN1820 150 mg SC n = 5	Cohort 4: ALXN1820 450 mg SC n = 5	Cohort 5: ALXN1820 450 mg IV n = 5	Cohort 6: ALXN1820 1200 mg SC n = 6	Cohort 8: ALXN1820 150 mg SC (QW*5) n = 7	Cohort 9: ALXN1820 150 mg SC (QW*5) n = 6	All Placebo n = 15
Value	1	0	0	4	2	0	1	3	2

Population analysed: The Safety Set included all participants who received at least 1 dose of study drug.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 155. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: ALXN1820 12.5 mg SC	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Cohort 2: ALXN1820 50 mg SC	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Cohort 3: ALXN1820 150 mg SC	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Cohort 4: ALXN1820 450 mg SC	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Cohort 5: ALXN1820 450 mg IV	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Cohort 6: ALXN1820 1200 mg SC	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Cohort 8: ALXN1820 150 mg SC (QW*5)	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
Cohort 9: ALXN1820 150 mg SC (QW*5)	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
All Placebo	0 of 15 (0%)	11 of 15 (73.3%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40134111Sandhu A, Shen T, Herrero PM, Yuan CX, Qureshi S, Jiang X, Sheng Y, Gasteyger C, Dai Y. Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ALXN1820 (Tarperprumig) in Healthy Adults: Results of a Phase I Study. Clin Transl Sci. 2025 Apr;18(4):e70190. doi: 10.1111/cts.70190.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ALXN1820 SC and ALXN1820 IV in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-related Adverse Events (TEAEs) For ALXN1820 SC And ALXN1820 IV (time frame: Cohorts 1 to 6: Baseline up to Day 127; Cohorts 8 to 9: Baseline up to Day 155). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04631562, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.